Phase ii Clinical Trials

Phase 2 clinical trials and clinical research. When testing drugs in humans phase ii trials are important for gathering information on how a drug effects a larger group of humans than in a phase 1 clinical trial. The phase 2 clinical trials are the step in the procedure of human testing that is done when the safety of a drug has been confirmed but it is still far from on the verge of being ready to be put on the market to sell to the general public. This type of trial also gauges how well a drug is working for humans and what side effects a drug may have. It is interesting to note that the phase II trials are often the step in the process of testing a drug when the drug is discovered to fail. This can be because the side effects are too severe for the drug to be of any benefit to humans or because the drug does not work as it has been planned to. When animal testing is done in the preclinical stage a drug can have a different effect on the animals then the later effect on humans, this could be a main reason that a drug may be rejected in phase 2 clinical trials.

When it comes to the design of these types of experiments for medical research they are usually designed as a case series. In regards to this a case series is used to note the safety and the effect of a drug in select patients. In addition to a case series another phase II trial is the type that is called a randomized clinical trial. During this type of experiment some patients will get a certain drug or a device and other patients will get placebos. The purpose of this is to gauge whether a patient gets significantly better because of the drug or device, or whether there is a psychological explanation for a patient getting better.